Ironwood Pharmaceuticals is trading at $3.56, down 5.32%, after the FDA sought a new confirmatory Phase 3 trial before considering apraglutide approval for short bowel syndrome.
- The FDA’s concern stems from lower-than-planned drug exposure and dosing issues in the earlier STARS trial.
- Ironwood said it is working with the FDA on trial design and the regulatory path forward.
- Biotech-sector weakness may add pressure, though the trial news is the clearest company-specific catalyst.